CHICAGO, July 23, 2024–(BUSINESS WIRE)–MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, “the Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced positive treatment progress in THIO-101, a Phase 2 clinical trial evaluating THIO in combination with the immune checkpoint inhibitor (CPI) cemiplimab (Libtayo®) in patients with advanced non-small cell lung cancer (NSCLC) who have failed two or more standard treatment regimens.
The treatment regimen in the trial is cycled every 3 weeks, with THIO 180 mg in 60 mg increments on days 1, 2, and 3, immune activation (no administration) on day 4, and cemiplimab 350 mg on day 5. As of the latest clinical cutoff date of June 12, 2024:
Six patients have completed at least 12 months of treatment and are continuing treatment.
THIO followed by cemiplimab was well tolerated throughout the trial and demonstrated much less toxicity than standard treatment.
Continuation of treatment beyond 12 months will demonstrate the safety, efficacy and continued benefit of MAIA’s novel telomere-targeted NSCLC treatment.
“The longest-treated patient to date has completed 21 cycles of THIO sequences with CPI, with six patients remaining on treatment beyond the 12-month survival follow-up,” said Vlad Vitoc, MD, Chairman and CEO of MAIA. “With current therapies, second-line patients typically receive treatment for approximately three to four months, and even less in third-line. It is very encouraging that patients can continue treatment for an even longer period. The continued benefit of THIO in long-term patients is particularly striking, suggesting that THIO may be a durable and effective treatment for patients with advanced NSCLC who have limited options.”
https://www.sciencedirect.com/science/article/pii/S0169500217304373
About THIO
THIO (6-thio-dG or 6-thio-2′-deoxyguanosine) is a first-in-class telomere-targeting investigational drug currently in clinical development to evaluate activity in non-small cell lung cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a critical role in cancer cell survival and resistance to current therapies. The modified nucleotide 6-thio-2′-deoxyguanosine (THIO) induces telomerase-dependent telomeric DNA modifications, DNA damage response, and selective cancer cell death. THIO-damaged telomeric fragments accumulate in cytoplasmic micronuclei and activate both innate (cGAS/STING) and adaptive (T cells) immunity. Sequential treatment with THIO followed by a PD-(L)1 inhibitor resulted in significant and durable tumor regression in advanced in vivo cancer models through induction of cancer type-specific immune memory. THIO is currently being developed as a second-line or later treatment for patients with NSCLC who have progressed beyond existing standard-of-care treatment regimens with checkpoint inhibitors.
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About the THIO-101 Phase 2 Clinical Trial
THIO-101 is a multicenter, open-label, dose-ranging Phase 2 clinical trial. It is the first study designed to evaluate the antitumor activity of THIO following administration of a PD-(L)1 inhibitor. The study is testing the hypothesis that low-dose THIO administered prior to cemiplimab (Libtayo®) enhances and sustains immune responses in patients with advanced NSCLC who have previously failed to respond or have developed resistance and progressed following a first-line treatment regimen that includes another checkpoint inhibitor. The study design has two primary objectives: (1) to evaluate the safety and tolerability of THIO administered as an anticancer compound and a priming immune activator, and (2) to evaluate the clinical efficacy of THIO using overall response rate (ORR) as the primary clinical endpoint. Cemiplimab (Libtayo®) followed by THIO has historically been generally well tolerated in a heavily pretreated population. For more information about this Phase II trial, please visit ClinicalTrials.gov using identifier NCT05208944.
About MAIA Biotechnology, Inc.
MAIA is a targeted therapy and immuno-oncology company focused on developing and commercializing potential first-in-class medicines with novel mechanisms of action aimed at significantly improving and extending the lives of cancer patients. The company’s lead program is THIO, a potential first-in-class cancer telomere-targeting drug in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.
Forward-Looking Statements
MAIA cautions that all statements other than statements of historical fact contained in this press release are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties and other factors that may cause the actual results, levels or activities, performance or achievements of the Company or its industry to differ materially from those projected by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” “continue” and other similar expressions are intended to identify forward-looking statements. However, the absence of these words does not mean that a statement is not forward-looking.For example, all statements made by the Company regarding (i) the initiation, timing, costs, progress and results of preclinical and clinical studies and research and development programs, (ii) our ability to advance product candidates into clinical trials and successfully complete clinical trials, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize product candidates and improve manufacturing processes, (v) the rate and extent of market acceptance of product candidates, (vi) the size and growth potential of the markets for product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for product candidates are forward-looking statements. All forward-looking statements are based on current estimates, assumptions and expectations of the Company’s management that, while believed to be reasonable, are inherently uncertain. Forward-looking statements that express expectations or beliefs regarding future events are expressed in good faith and are believed to be reasonable at the time such forward-looking statements are made. However, these statements are not guarantees of future events and are subject to risks, uncertainties and other factors beyond our control that could cause actual results to differ materially from those expressed in the forward-looking statements. Forward-looking statements speak only as of the date on which they are made. The Company undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, references to “MAIA,” “the Company,” “we,” “our” and “us” refer to MAIA Biotechnology, Inc. and its subsidiaries.
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